Mode of Delivery on Newborn Hearing Test

Hearing Loss, Neonatal Clinical Trial

Official title:

The Effect of Mode of Delivery on Automated Auditory Brainstem Response (AABR) Test

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03881514
• Other study ID #: 2018.9.16
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: June 1, 2019

Study information

• Verified date: January 2020
• Source: Kanuni Sultan Suleyman Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Neonatal hearing screening may fail due to some perinatal and neonatal factors. It is well known that false positivity increases cost and maternal anxiety and anxiety in the neonatal hearing screening. The effect of the type of delivery to hearing screening is not yet clear. The first automated mode of delivery of babies born in Turkey auditory brainstem response (SAD's), the authors aimed to evaluate the effects of the test results and false positive rate.

newborns were evaluated with brainstem response test. The AABR test was performed before patients were discharged. Perinatal and neonatal variables and AABR test results were recorded retrospectively.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: June 1, 2019
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• records of birth process and

• pregnancy test results of newborns.

Exclusion Criteria:

• newborn;

• She was in a neonatal intensive care,

• congenital / chromosomal anomaly,

• undergoing congenital cmv infection,

• facial / ear deformity,

• families with hearing problems,

• those with hyperbiliromyemia,

• <12 hours after delivery,

• maternal infection,

• dm,

• recurrent abortion,

• smoking,

• plesanta previa,

Related Conditions & MeSH terms

• Hearing Loss
• Hearing Loss, Neonatal

Locations

Country	Name	City	State
Turkey	Kanuni Sultan Süleyman Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	newborn hearing screening results	hearing test results of newborns. The test results will be grouped according to the type of birth. The effect of the type of delivery on hearing test results will be investigated. The relationship between vaginal route and cesarean section and hearing test will be the first results.; hearing test results were evaluated separately for the right and left ear as 'passed the test' and 'left test'.	1 week after delivery